NCT03533309

Brief Summary

In patient with horizontal deficiency in alveolar ridge of the anterior maxilla, Dose computer Guided stent enhance the accuracy and clinical outcome vs conventional ridge splitting surgery????

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

May 11, 2018

Last Update Submit

May 22, 2018

Conditions

Keywords

horizontal defect, Anterior maxillary

Outcome Measures

Primary Outcomes (1)

  • Accuracy

    In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm)

    up to 4 months

Secondary Outcomes (1)

  • Thickness of buccal cortical plate

    up to 4 months

Study Arms (2)

computer guided

EXPERIMENTAL

Group (A): comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent. .

Procedure: Computer guided surgical cutting guide

conventional

ACTIVE COMPARATOR

Group (B) comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique

Procedure: Conventional alveolar ridge splitting

Interventions

comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent

computer guided

comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique.

conventional

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Partial edentulous in the aesthetic zone.
  • Patient with bucco-lingual bone width is 3 mm or greater but \< 6mm
  • Normal alveolar bone height
  • Adequate oral hygiene
  • Free of soft tissue or dental pathology
  • Patients accepting to participate in the study

You may not qualify if:

  • Patient medically compromised.
  • Uncooperative patient.
  • Poor oral hygiene and periodontal disease.
  • Patients who smoked and pregnant women
  • Systemic disease directly affecting bone healing
  • Atrophic ridges (1.5 mm or less)
  • History of radiotherapy \& treatment with bisphosphonates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

July 1, 2018

Primary Completion

July 30, 2019

Study Completion

October 30, 2019

Last Updated

May 24, 2018

Record last verified: 2018-05